Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial
Background: Diabetic neuropathic pain (DNP) is a common complication of diabetes and has a profound effect on patients quality of life. Therefore. The purpose of the present study was to compare the analgesic effects of duloxetine and nortryptiline in the management of patients with diabetic neurop...
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| Format: | Article |
| Language: | English |
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Babol University of Medical Sciences
2021-01-01
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| Series: | Caspian Journal of Internal Medicine |
| Subjects: | |
| Online Access: | http://caspjim.com/article-1-2354-en.html |
| _version_ | 1818615862158950400 |
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| author | Mohammadali Bayani Babak Moazammi Farshad Fadaee-Jouybari Mansour Babaei Alijan Ahmadi-Ahangar Payam Saadat |
| author_facet | Mohammadali Bayani Babak Moazammi Farshad Fadaee-Jouybari Mansour Babaei Alijan Ahmadi-Ahangar Payam Saadat |
| author_sort | Mohammadali Bayani |
| collection | DOAJ |
| description | Background: Diabetic neuropathic pain (DNP) is a common complication of diabetes and has a profound effect on patients quality of life. Therefore. The purpose of the present study was to compare the analgesic effects of duloxetine and nortryptiline in the management of patients with diabetic neuropathy.
Methods: This was a randomized, double-blind, parallel-group, placebo-controlled trial in subjects with a proven diagnosis of DM and suffered from neuropathic pain. Patients were recruited in this study from 20 February 2016 (first patient, first visit) to 22 June 2017 (last patient, last visit), including 5 weeks follow-up. A diagnosis of DNP was based on history, clinical examination, Nerve conduction velocity and Diabetic neuropathy symptom score (more than one point).
Results: Both drugs reduced pain when compared with placebo. A significant VAS reduction from 6.4 at baseline to 3.75 at endpoint was observed in the duloxetine group. However, there was no significant difference in the efficacy between nortriptyline and duloxetine based on patientchr('39')s visual analogue scale (VAS) (p>0.05). No clinically significant changes or serious adverse events were found among treatment groups including changes in vital signs, laboratory assessments, physical examination or electrocardiograms. The decrease in the mean pain intensity was significantly greater in the duloxetine and nortriptyline group compared to the placebo group both in the primary analysis and in the by-visit analysis (p<0.003)
Conclusions: The present study demonstrates the safety and effectiveness of both duloxetine and nortriptyline in the management of DNP. |
| first_indexed | 2024-12-16T16:40:39Z |
| format | Article |
| id | doaj.art-236400afcd1b48bfb658f72111c6df02 |
| institution | Directory Open Access Journal |
| issn | 2008-6164 2008-6172 |
| language | English |
| last_indexed | 2024-12-16T16:40:39Z |
| publishDate | 2021-01-01 |
| publisher | Babol University of Medical Sciences |
| record_format | Article |
| series | Caspian Journal of Internal Medicine |
| spelling | doaj.art-236400afcd1b48bfb658f72111c6df022022-12-21T22:24:19ZengBabol University of Medical SciencesCaspian Journal of Internal Medicine2008-61642008-61722021-01-011212934Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled TrialMohammadali Bayani0Babak Moazammi1Farshad Fadaee-Jouybari2Mansour Babaei3Alijan Ahmadi-Ahangar4Payam Saadat5 Department of Internal Medicine, Babol University of Medical sciences, Babol, Iran Babol Universtiy of Medical sciences, Babol, Iran Babol Universtiy of Medical sciences, Babol, Iran Department of Internal Medicine, Babol University of Medical sciences, Babol, Iran Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran Background: Diabetic neuropathic pain (DNP) is a common complication of diabetes and has a profound effect on patients quality of life. Therefore. The purpose of the present study was to compare the analgesic effects of duloxetine and nortryptiline in the management of patients with diabetic neuropathy. Methods: This was a randomized, double-blind, parallel-group, placebo-controlled trial in subjects with a proven diagnosis of DM and suffered from neuropathic pain. Patients were recruited in this study from 20 February 2016 (first patient, first visit) to 22 June 2017 (last patient, last visit), including 5 weeks follow-up. A diagnosis of DNP was based on history, clinical examination, Nerve conduction velocity and Diabetic neuropathy symptom score (more than one point). Results: Both drugs reduced pain when compared with placebo. A significant VAS reduction from 6.4 at baseline to 3.75 at endpoint was observed in the duloxetine group. However, there was no significant difference in the efficacy between nortriptyline and duloxetine based on patientchr('39')s visual analogue scale (VAS) (p>0.05). No clinically significant changes or serious adverse events were found among treatment groups including changes in vital signs, laboratory assessments, physical examination or electrocardiograms. The decrease in the mean pain intensity was significantly greater in the duloxetine and nortriptyline group compared to the placebo group both in the primary analysis and in the by-visit analysis (p<0.003) Conclusions: The present study demonstrates the safety and effectiveness of both duloxetine and nortriptyline in the management of DNP.http://caspjim.com/article-1-2354-en.htmldiabetic peripheral neuropathynortriptylineduloxetinediabetespain |
| spellingShingle | Mohammadali Bayani Babak Moazammi Farshad Fadaee-Jouybari Mansour Babaei Alijan Ahmadi-Ahangar Payam Saadat Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial Caspian Journal of Internal Medicine diabetic peripheral neuropathy nortriptyline duloxetine diabetes pain |
| title | Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full | Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_fullStr | Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full_unstemmed | Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_short | Analgesic Effect of Duloxetine Compared to Nortryptiline in Patients with painful Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Trial |
| title_sort | analgesic effect of duloxetine compared to nortryptiline in patients with painful neuropathy a randomized double blind placebo controlled trial |
| topic | diabetic peripheral neuropathy nortriptyline duloxetine diabetes pain |
| url | http://caspjim.com/article-1-2354-en.html |
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